CMC Regulatory Director - Global Strategy & Submissions
$177k - $278.08kJobRx, Inc.
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position offers a hybrid work model and a competitive salary ranging from $177,000 to $278,080, alongside comprehensive benefits including health insurance, 401(k) plan, and paid time off. #J-18808-Ljbffr JobRx, Inc.
- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and... ...The candidate will prepare regulatory submissions, interact with health authorities like... ...role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema...Suggested
$246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...SuggestedFlexible hours$137k - $215.27k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...registration and/or post-approval strategies for assigned products. RA... ...development of robust and accurate submissions. Develops constructive...SuggestedMinimum wageFull timeTemporary workLocal areaImmediate startRemote workWorldwide$177k - $278.08k
...worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization,... ...develops the regulatory CMC strategy and leads the execution of... ...aspects of global registrational submissions of complex drug product or...SuggestedMinimum wageTemporary workLocal areaImmediate startRemote workWorldwide$177k - $278.08k
.... This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...develops the regulatory CMC strategy and leads the execution of regulatory... ...of global registrational submissions of complex drug product or...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide... ...robust, fit-for-phase regulatory strategies for small molecule and biologic... ...global CMC regulatory strategy and key submissions/health authority interactions for...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing &... ...successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold a...
- ...therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and... ...respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors...Local areaImmediate startWorldwide
$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...innovative and robust regulatory strategies for medical devices and drug‑device... ...regulatory strategy and major submissions for an assigned portfolio of medical...Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$137k - $215.27k
...for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device... .... Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a...$196.7k - $353.4k
Senior Director, Global Regulatory Strategy, Oncology page is loaded## Senior Director, Global Regulatory Strategy, Oncologylocations: Cambridge, Massachusetts... ...through commercialization* Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgency*...Work at officeWork from home- Initial Therapeutics, Inc. is seeking a seasoned regulatory leader to develop and execute global regulatory strategy for its oncology portfolio. The role requires... ...Key responsibilities include leading regulatory submissions and health authority interactions, anticipating...
$200k - $260k
...leading consulting firm in health strategy seeks a Senior Director of Regulatory Strategy Consulting in Boston. In... ...substantial regulatory experience to shape global strategies and lead cross-... ...experience managing complex regulatory submissions. The targeted compensation ranges...Flexible hours$211.85k - $317.78k
...patients' lives. This is what you will do: The Senior Regulatory Affairs Director (Sr RAD), Global Regulatory Strategy, leads the development and implementation of... ...assets from early development through global submission and approval. May serve in a dual role as GRL and...Hourly payTemporary workWork at officeFlexible hours3 days per week- ...Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This... ...developing and executing regulatory strategies to support global product development, particularly... ...the ability to manage regulatory submissions and work with health authorities such...
- ...Senior CMC Regulatory Submission Manager A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the... ...management and oversight of the CMC Regulatory Submissions for Global Portfolio of early development programs (IMPD/CTA/IND). The...
- ...biopharmaceutical company is seeking a Director of Regulatory CMC in Boston, MA. This key role involves... ...activities, ensuring compliance with global regulations, and leading efforts to... ...external partners while driving innovative regulatory strategies. #J-18808-Ljbffr Takeda
- Takeda in Boston is looking for a GRA CMC Product Lead to oversee regulatory CMC strategies and lead submissions for investigational, registration, and post-approval processes. This role requires a strong background in biopharmaceuticals with 10+ years in the industry...
- ...biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory... ...Affairs experience, particularly with CMC requirements for Small Molecule drugs....Work at office
$200k - $260k
Senior Director, Regulatory Strategy Consulting Are you looking for a company that is... ...will shape and drive global regulatory strategies across... ...of major global regulatory submissions (INDs, CTAs, NDAs, BLAs) and... ...development, and/or regulatory CMC. Experience across...Full timeLocal areaRemote workVisa sponsorshipFlexible hours$211.85k - $317.78k
AstraZeneca GmbH in Boston is seeking a Senior Regulatory Affairs Director to lead the global regulatory strategy for rare disease programs. The successful candidate will have an advanced degree and 10+ years of relevant experience, guiding cross-functional teams and managing...$148k - $206k
A global private markets firm is seeking a Director of Tax Compliance in Boston. The ideal candidate will oversee U.S. and global tax compliance processes, lead ASC 740, and manage external advisors. Strong knowledge of private market funds and at least 10 years of tax...Remote work- A leading BioPharmaceutical company seeks a Senior Director, Global Regulatory Strategy, to lead regulatory efforts for early-stage products and ensure alignment with health authority expectations. The role demands extensive regulatory experience in the pharmaceutical...
$211.85k - $317.78k
Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately...Hourly payTemporary workWork at office3 days per week- Akebia Therapeutics is seeking a Director of Regulatory Affairs - Labeling to lead the global labeling strategy across its portfolio. The position requires extensive experience in regulatory labeling and the ability to influence cross-functional teams while ensuring compliance...
- ...leading oncology biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing strategic... ..., ensuring compliance, and overseeing global regulatory strategies. The ideal candidate will have over 15 years of...
$187.5k - $275k
Senior Director Regulatory Strategy page is loaded## Senior Director Regulatory Strategylocations... ...around the world. We are a global healthcare leader... ...regulatory strategy, submissions, and compliance activities... ...clinical, nonclinical, and CMC regulatory strategy including...Full timeWork at officeFlexible hours3 days per week- ...abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and...Temporary workLocal areaWorldwide
$177k - $278.08k
...patients worldwide. The Director Regulatory Site CMC ensures efficient and... ...practical experience with global HA requirements, beyond EU... ...and communicate regulatory strategy to drug development, registration... ...and regulatory submissions (considering possible strategic...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$150.03k - $224.25k
...Provides critical support in developing global regulatory strategy, planning and execution of global... ...investigational and marketed prescription drug submissions and manages lifecycle activities for... ...team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory...Temporary workWork at officeLocal areaFlexible hours
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